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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K896036
Device Name THE COMFORTABLE CANNULA
Applicant
Comfortable Concepts Corp.
102 Ralph Ave.
Copiague,  NY  11726
Applicant Contact ANDREW N WEISS
Correspondent
Comfortable Concepts Corp.
102 Ralph Ave.
Copiague,  NY  11726
Correspondent Contact ANDREW N WEISS
Regulation Number868.5340
Classification Product Code
CAT  
Date Received10/17/1989
Decision Date 11/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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